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REVIEW ARTICLE |
Department of Psychological Medicine, Cardiff University
Institute Institute of Psychiatry, King’s College London
National Collaborating Centre for Mental Health, London
Department of Mental Health, University of York
University College London, London, UK
Correspondence: Dr Jonathan Bisson, Department of Psychological Medicine, Monmouth House, University Hospital of Wales, Heath Park, Cardiff CF14 4XN, UK. Email: bissonji{at}cf.ac.uk
*Studies that were part of the meta-analysis.
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ABSTRACT |
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 TOP ABSTRACT INTRODUCTIONMETHODRESULTSDISCUSSIONAPPENDIXREFERENCES |
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Aims To determine the efficacy of specific psychological treatments for chronic PTSD.
Method In a systematic review of randomised controlled trials, eligible studies were assessed against methodological quality criteria and data were extracted and analysed.
Results Thirty-eight randomised controlled trials were included in the meta-analysis. Trauma-focused cognitive–behavioural therapy (TFCBT), eye movement desensitisation and reprocessing (EMDR), stress management and group cognitive–behavioural therapy improved PTSD symptoms more than waiting-list or usual care. There was inconclusive evidence regarding other therapies. There was no evidence of a difference in efficacy between TFCBT and EMDR but there was some evidence that TFCBT and EMDR were superior to stress management and other therapies, and that stress management was superior to other therapies.
Conclusions The first-line psychological treatment for PTSD should be trauma-focused (TFCBT or EMDR).
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INTRODUCTION |
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TOPABSTRACTINTRODUCTIONMETHODRESULTSDISCUSSIONAPPENDIXREFERENCES |
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METHOD |
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TOPABSTRACTINTRODUCTIONMETHODRESULTSDISCUSSIONAPPENDIXREFERENCES |
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A systematic bibliographic search was undertaken to find randomised controlled trials of psychological treatments for PTSD from databases (EMBASE, Medline, PsycINFO and CINAHL) and the Cochrane Library, with each database being searched from inception to August 2004. Additional papers were found by hand-searching the references of retrieved articles, previous systematic reviews and meta-analyses of psychological treatments for PTSD. The search was restricted to papers with English-language abstracts. In addition, data from unpublished studies or papers in press were sought by contacting experts within the field.
Selection
Studies were only considered if PTSD symptoms were the main target of
treatment, all participants had had PTSD symptoms for at least 3 months
following a traumatic event, at least 70% of participants had a diagnosis of
PTSD, and PTSD symptoms were measured using a recognised scale. To be included
studies had to be of randomised controlled design, with adult (>16 years
old) participants; the studies had to report at least pre-treatment and
post-treatment measures, and retain at least 50% of the original sample at the
post-treatment assessment. There was no restriction regarding type of
traumatic event. The minimum duration of symptoms was 1 month. Early
intervention trials that only included participants with recent onset of PTSD
were not included and are considered in a separate review (further details
available from the author upon request). The searching and selection were done
by a team of systematic reviewers led by R.M. Any disagreements with regard to
inclusion or exclusion of a study were resolved by discussion with the other
authors.
Validity assessment
All published and unpublished papers were assessed against the following
quality criteria: random sequence generation, concealment of allocation,
masked assessment of outcomes, number of withdrawals, tolerability, adequate
reporting of data and intention-to-treat analysis.
Data abstraction
Study details including the nature of the traumatic events,
participants’ characteristics and type of intervention were entered into
a Microsoft Access database (version 2000), the quality criteria were applied
and outcome data for included studies were entered into Review Manager version
4.2.3 for Windows. The application of quality criteria and the accuracy of
outcome data were double-checked by a second reviewer.
Study characteristics
An initial narrative synthesis was undertaken to describe the scope
(participants, settings, intervention type, comparators, measures of effect),
quality and outcomes of the studies. Three main efficacy outcomes were
considered: one dichotomous outcome (retaining a diagnosis of PTSD) and two
continuous outcomes (assessor-rated and self-reported severity of PTSD
symptoms). Among the main outcomes, the primary outcome was clinician-rated
severity of PTSD symptoms, although this was not present for all studies.
Quantitative data synthesis
Where possible, meta-analysis was used to synthesise data, including
additional meta-analyses for anxiety and depression measures where available,
and numbers leaving the study early, using Review Manager. Post-treatment data
(or change scores if reported instead of post-treatment data) for the
psychological treatment and control condition were entered in the Review
Manager tables. Dichotomous outcomes (PTSD diagnosis and leaving the study
early for any reason) were analysed as a relative risk number and were
calculated on an intention-to-treat basis (i.e. a ‘once randomised
always analyse’ basis). This makes the conservative assumption that all
participants who ceased to engage in the study had an unfavourable outcome,
e.g. they left because the treatment was not acceptable and still had a
diagnosis of PTSD. Continuous outcomes were analysed as standardised mean
differences (SMDs) to allow for ease of comparison across studies. It was not
possible to obtain intention-to-treat data for most of the trials, and we
therefore used completer data for all continuous outcomes.
For consistency of presentation all data were entered into Review Manager in such a way that negative effect sizes or relative risk numbers less than 1 represented an effect that favoured the active treatment compared with the waiting-list control. Data were pooled from more than one study using a fixed-effects meta-analysis except where heterogeneity was present, in which case a random-effects model was used as described below.
Heterogeneity
To check for heterogeneity between studies, both the
I2-test of heterogeneity and the 
2-test of
heterogeneity (P<0.10) as well as visual inspection of the forest
plots were used. The I2 statistic describes the proportion
of total variation in study estimates that is due to heterogeneity
(Higgins & Thompson,
2002). An I2 of less than 30% was taken to
indicate mild heterogeneity and a fixed-effects model was used to synthesise
the results. An I2 of more than 50% was taken as notable
heterogeneity; in this case an attempt was made to explain the variation. If
studies with heterogeneous results were found to be comparable, a
random-effects model was used to summarise the results
(DerSimonian & Laird,
1986). In the random-effects analysis, heterogeneity is accounted
for both in the width of confidence intervals and in the estimate of the
treatment effect. With decreasing heterogeneity the random-effects approach
moves asymptotically towards a fixed-effects model. An I2
of 30–50% was taken to indicate moderate heterogeneity. In this case,
both the 2-test of heterogeneity and a visual inspection of
the forest plot were used to decide between a fixed- and random-effects
model.
In order to explore heterogeneity further, sensitivity analyses were performed to consider the influence of higher-quality methodology (this was done by considering studies that used masked assessment, and those that used an intention-to-treat analysis), studies that only included females and those that only included Vietnam veterans.
Clinical effectiveness
Where psychological interventions were compared against waiting-list
control groups an effect size (SMD) of –0.8 or less (e.g. a larger
negative number) was considered clinically meaningful for continuous variables
(a ‘large’ effect size; Cohen,
1988) and for dichotomous outcomes a relative risk of 0.65 or less
(or greater than 1.54) was considered clinically meaningful. Where two active
treatments were compared lower thresholds were set with an SMD of –0.5
or +0.5 for continuous variables (a ‘medium’ effect size), and for
dichotomous outcomes a relative risk of 0.80 or less or 1.25 or greater was
considered clinically meaningful. These thresholds came from discussions in
the NICE Guideline Development Group in advance of undertaking the
meta-analyses and were based on clinical experience and thresholds used in the
literature (Schnurr et al,
2003). In order to be considered clinically meaningful the value
had to meet the threshold criterion and the 95% confidence interval had to be
greater than the threshold. If the SMD and relative risk met the threshold
criterion but the 95% CI included values in the non-clinically significant
range, this was interpreted as limited evidence for an effect. Similarly, if
the SMD or relative risk value was below the threshold, the 95% CIs were
examined to determine whether the evidence was inconclusive (in case the 95%
CI included numbers greater than the threshold) or whether it could be stated
that there was evidence suggesting that an effect was unlikely (where the 95%
CI was entirely outside the clinically meaningful range).
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RESULTS |
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TOPABSTRACTINTRODUCTIONMETHODRESULTSDISCUSSIONAPPENDIXREFERENCES |
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Study characteristics
Details of the studies included appear in the data supplement to the online
version of this article. Twenty-five studies compared trauma-focused
cognitive–behavioural therapy (TFCBT) with waiting-list or other
psychological interventions: Blanchard et al
(2003), Brom et al
(1989), Bryant et al
(2003), Cloitre et al
(2002), Cooper & Clum
(1989), Devilly & Spence
(1999), Echeburua et
al (1997), Ehlers et
al (2005), Fecteau &
Nicki (1999), Foa et
al (1991,
1999), Gersons et al
(2000), Ironson et al
(2002), Keane et al
(1989), Kubany et al
(2003), Kubany et al
(2004), Lee et al
(2002), Marks et al
(1998), Paunovic & Ost
(2001), Peniston &
Kulkosky (1991), Power et
al (2002), Resick et
al (2002), Rothbaum
et al (2005), Taylor
et al (2003) and
Vaughan et al (1994).
Twelve studies compared eye movement desensitisation and reprocessing (EMDR)
with waiting-list or other psychological interventions: Carlson et al
(1998), Devilly & Spence
(1999), Ironson et al
(2002), Jensen
(1994), Lee et al
(2002), Marcus et al
(1997), Power et al
(2002), Rothbaum
(1997), Rothbaum et
al (2005), Scheck et
al (1998), Taylor et
al (2003) and Vaughan
et al (1994). Seven
studies compared stress management with waiting-list or other psychological
interventions: Carlson et al
(1998), Echeburua et
al (1997), Foa et
al (1991,
1999), Marks et al
(1998), Taylor et al
(2003) and Vaughan et
al (1994). Six studies
compared ‘other therapies’ with waiting-list or other
psychological interventions: Blanchard et al
(2003), Brom et al
(1989), Bryant et al
(2003), Foa et al
(1991), Marcus et al
(1997) and Scheck et
al (1998). Four studies
compared group cognitive–behavioural therapy with waiting-list or other
psychological interventions: Classen et al
(2001), Krakow et al
(2001), Schnurr et al
(2003) and Zlotnick et
al (1997).
Two additional randomised controlled trials met inclusion criteria but differed in mode of delivery (Lange et al, 2003; Neuner et al, 2004), and one further trial compared two versions of TFCBT (exposure and cognitive therapy) with each other (Tarrier et al, 1999a,b). These studies could not be included in the meta-analysis.
Quantitative data synthesis
Table 1 provides details of
the quantitative data synthesis. It highlights that TFCBT and EMDR were better
than waiting-list/control on most outcome measures. Stress management was
better on some outcomes, and ‘other therapies’ appeared to be the
least effective. Unfortunately none of the studies reported adverse effects
and therefore it was not possible to analyse these. However, most studies did
report withdrawal rates and these are included in
Table 1.
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Sensitivity analyses
Masked assessment
The EMDR studies using masked assessment showed evidence favouring EMDR
over waiting-list on reducing the severity of PTSD symptoms (clinician-rated
measures) (three studies, n=120; SMD=–1.54, 1.54, 95% CI
–1.95 to –1.12) similar to that in all EMDR studies (see
Table 1). The TFCBT studies
using masked assessment showed evidence favouring TFCBT over waiting-list on
reducing the severity of PTSD symptoms (clinician-rated measures) (seven
studies, n=308; SMD=–1.70; 95% CI –2.47 to –0.93)
similar to that in all TFCBT studies.
Vietnam veteran studies
One EMDR study considered only Vietnam veterans. This showed less evidence
favouring EMDR over waiting-list on reducing the severity of PTSD symptoms
(clinician-rated measures) (one study, n=25; SMD=–0.97, 95% CI
–1.81 to –0.13) than the other EMDR studies (see
Table 1). One TFCBT study
considered only Vietnam veterans using the primary outcome measure; this
showed less evidence favouring TFCBT over waiting-list on reducing the
severity of PTSD symptoms (clinician-rated measures) (one study,
n=24; SMD=–0.22, 95% CI –1.03 to 0.58) than the other
TFCBT studies.
Female studies
The EMDR studies including only female participants showed evidence
favouring EMDR over waiting-list on reducing the severity of PTSD symptoms
(clinician-rated measures) (two studies, n=57; SMD= –1.67, 95%
CI –2.30 to –1.04) similar to that in all EMDR studies. The TFCBT
studies including only female participants showed more evidence favouring
TFCBT over waiting-list on reducing the severity of PTSD symptoms
(clinician-rated measures) (six studies, n=358; SMD=–2.06, 95%
CI –2.70 to –1.42) than all TFCBT studies.
Intention-to-treat analysis
None of the EMDR studies reported using an intention-to-treat analysis so
this could not be assessed. The TFCBT studies using an intention-to-treat
analysis showed more evidence favouring TFCBT over waiting-list on reducing
the severity of PTSD symptoms (clinician-rated measures) (six studies,
n=332; SMD=–1.82, 95% CI –2.76 to –0.89) than all
TFCBT studies.
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DISCUSSION |
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TOPABSTRACTINTRODUCTIONMETHODRESULTSDISCUSSIONAPPENDIXREFERENCES |
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The treatments most supported by the review (individually delivered TFCBT and EMDR) are both trauma-focused psychological treatments that specifically address the patient’s troubling memories of the traumatic event and the personal meanings of the event and its consequences. Direct comparisons of these two approaches did not reveal any significant advantages of one over the other, with respect to either treatment outcome or speed of therapeutic change (Taylor et al, 2003).
Heterogeneity
There is clearly considerable clinical diversity within the studies
considered. The separation of different active interventions into groups
partially addresses their impact on clinical diversity, but not all trials
within the same group used identical interventions. The differences were most
marked in the ‘other therapy’ group, which had in common the
absence of cognitive–behavioural techniques and trauma-focused work.
There was also diversity in the TFCBT group, which included both exposure-only
and trauma-focused cognitive therapy interventions.
Another source of heterogeneity was the quality of the studies. Sensitivity analyses of higher-quality and lower-quality studies were performed to explore this further. There was some limited evidence that higher-quality studies (those including masked assessment of outcome or intention-to-treat analysis) showed better outcomes than the lower-quality studies. This finding contradicts previous research (Moher et al, 1998) that has found an association between poorer methodology and more favourable results for the intervention. It may reflect the fact that the better studies tended to be more recent and associated with refinement of techniques. They also included most of the female-only studies. The fact that female-only studies showed a better response to TFCBT than mixed studies and male-only studies is difficult to interpret. It may be that the female-only studies used more effective interventions, that the trauma of rape is more amenable than other traumas to effective TFCBT, or that for some undetermined reason women are more responsive to TFCBT than men. Interestingly, a similar superiority in female response has been found for pharmacological treatment of PTSD (National Collaborating Centre for Mental Health, 2005). The finding that studies including only Vietnam veterans produced worse responses to TFCBT and EMDR might have contributed to the female studies finding and also suggests that Vietnam veterans are a particularly difficult population to treat.
As with all psychological treatment trials, there are issues with the control group. The development of a psychological treatment placebo is difficult, if not impossible, as is masking of participants and therapists. In several of the waiting-list or usual care conditions it was apparent that some (usually poorly defined) treatment was going on. The main effect of this is likely to have made it more difficult for the active intervention to show itself to be superior to the control condition.
Tolerability
Unfortunately none of the studies reported adverse effects. It remains
unclear whether no adverse effects occurred, or whether they were not
described. This is a key short-coming in the trials identified. Most studies
reported withdrawals by group. There are likely to be several different
factors that determine withdrawal rates, including the tolerability of the
intervention. There was limited evidence that TFCBT and other therapies fared
worse than waiting-list or usual care on this outcome measure, but there was
no significant difference in withdrawal rates in direct comparisons between
any of the active treatments. The higher-quality TFCBT studies showed no
difference in withdrawal rates when compared with waiting-list or usual care.
Some people find it difficult to fully engage in psychological treatment
because it requires a significant commitment of time and emotion. For some
people with PTSD it may initially be difficult and overwhelming to disclose
details of their traumatic events. It is also well recognised that some
patients may be subject to initial adverse effects such as increased
re-experiencing following exposure treatment
(Pitman et al, 1991;
Foa et al, 2002;
Hackmann et al,
2004). Withdrawal rates of up to 30% in some studies suggest that
the active treatments were not always acceptable to those receiving them. It
is possible that in these cases devoting several sessions to establishing a
trusting therapeutic relationship and emotional stabilisation, before
addressing the traumatic event, might lead to greater acceptability.
Limitations of the meta-analysis
Although this meta-analysis provides a systematic and comprehensive
comparison of the different psychological treatments of PTSD, it is not
without methodological problems. The randomised controlled trials analysed
usually reported unadjusted means for the treatment conditions after therapy
and at follow-up. Sample sizes were usually small, raising the chance that
baseline differences present before treatment influenced scores after
treatment. Indeed, some studies showed baseline differences between the study
conditions that remained uncorrected in our analysis. However, across studies
no systematic baseline difference existed, so the conclusions remain valid.
Furthermore, the Review Manager program does not allow entering a score of 0
for both groups. Thus, the withdrawal rates reported are slight overestimates
of the true rates.
Clinical implications
Our results suggest that trauma-focused psychological treatments (TFCBT or
EMDR) are effective for chronic PTSD. Indeed, the effect sizes compare
favourably with those found for cognitive–behavioural therapy in
depressive and anxiety disorders (National
Collaborating Centre for Mental Health, 2004;
National Collaborating Centre for Primary
Care, 2004). These treatments are normally delivered on an
individual out-patient basis over 8–12 sessions. A course of
trauma-focused psychological treatment should be offered to everyone with
chronic PTSD. The results also suggest that not all chronic PTSD will benefit
from these treatments; other approaches should then be considered, including
extending the number of sessions, trying an alternative form of trauma-focused
psychological treatment and the augmentation of trauma-focused psychological
treatment with a course of pharmacological treatment. A recent meta-analysis
has suggested that pharmacological interventions are unlikely to be as
clinically effective as trauma-focused psychological interventions and should
therefore be used as a second-line treatment
(National Collaborating Centre for Mental
Health, 2005).
Future research
Further well-designed trials of psychological treatments are required,
including further comparison studies of one type of psychological treatment
against another. There is a need for large-scale studies (phase 4) to find out
whether the results will survive in real practice. Future trials should
consider adverse events and tolerability of treatment in more detail. Our
results suggest that several of the currently available treatments might
benefit from modifications that would make them more acceptable to people with
chronic PTSD and possibly also more effective. There is also potential for
research concerning the direct comparison of psychological treatments with
pharmacological treatments, the effectiveness of a combination of the two, and
the implications of the high degree of comorbidity with other disorders for
the choice of treatment.
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APPENDIX |
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TOPABSTRACTINTRODUCTIONMETHODRESULTSDISCUSSIONAPPENDIXREFERENCES |
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Treatments delivered on an individual basis that do not place the main focus of treatment on the trauma
Treatments delivered in groups
5. Group cognitive–behavioural therapy.
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REFERENCES |
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TOPABSTRACTINTRODUCTIONMETHODRESULTSDISCUSSIONAPPENDIXREFERENCES |
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Received for publication January 5, 2006. Revision received April 27, 2006. Accepted for publication June 2, 2006.
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